T. Randolph

发表

Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation

John F. Carpenter, Theodore W. Randolph, J. Carpenter, 2003, Pharmaceutical Research.

Effects of drying methods and additives on the structure, function, and storage stability of subtilisin: role of protein conformation and molecular mobility

A. Gaertner, J. Carpenter, T. Randolph, 2002 .

Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry.

K. Menard, P. Setlow, M. Manning, 2008, Journal of pharmaceutical sciences.

Do not drop: mechanical shock in vials causes cavitation, protein aggregation, and particle formation.

Theodore W Randolph, Donn Sederstrom, Erwin Freund, 2015, Journal of pharmaceutical sciences.

Aggregation and Particle Formation During Pumping of an Antibody Formulation are Controlled by Electrostatic Interactions between Pump Surfaces and Protein Molecules.

T. Randolph, Hao Wu, 2020, Journal of pharmaceutical sciences.

Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions.

Austin L Daniels, T. Randolph, 2018, Journal of pharmaceutical sciences.

Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products.

W. Jiskoot, G. Winter, C. R. Middaugh, 2010, Journal of pharmaceutical sciences.

Congo Red Populates Partially Unfolded States of an Amyloidogenic Protein to Enhance Aggregation and Amyloid Fibril Formation*

M. Manning, J. Carpenter, T. Randolph, 2003, The Journal of Biological Chemistry.

Hydrogel Coatings on Container Surfaces Reduce Protein Aggregation Caused by Mechanical Stress and Cavitation

Austin L Daniels, Andrew P. Goodwin, C. Calderon, 2021, ACS Applied Bio Materials.

Scale-up criteria for an injector with a confined mixing chamber during precipitation with a compressed-fluid antisolvent

Corinne S. Lengsfeld, Theodore W. Randolph, Daniel J. Jarmer, 2006 .

Controlled release of ionic compounds from poly (l-lactide) microspheres produced by precipitation with a compressed antisolvent

M. Manning, T. Randolph, R. F. Falk, 1997 .

Mechanism of microparticle formation in the compressed antisolvent precipitation and photopolymerization (CAPP) process

Kristi S. Anseth, Theodore W. Randolph, K. Anseth, 2003 .

Effect of Tween 20 on freeze-thawing- and agitation-induced aggregation of recombinant human factor XIII.

M. Manning, S. Frokjaer, J. Flink, 1998, Journal of pharmaceutical sciences.

Atomic-Layer Deposition Processes Applied to Phage λ and a Phage-Like Particle Platform Yield Thermostable, Single-Shot Vaccines.

Qing Yang, C. Catalano, T. Randolph, 2022, Journal of pharmaceutical sciences.

Biocatalysis in Supercritical Fluids

H. Blanch, D. Clark, T. Randolph, 1991 .

Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges.

W. Jiskoot, M. Joubert, L. Narhi, 2016, Journal of pharmaceutical sciences.

Sub-visible Particles in IVIg Formulations Activate Complement in Human Serum.

T. Randolph, A. Frazer-Abel, C. F. Chisholm, 2020, Journal of pharmaceutical sciences.

The Effect of Container Surface Passivation on Aggregation of Intravenous Immunoglobulin Induced by Mechanical Shock

Andrew P. Goodwin, T. Randolph, Hao Wu, 2020, Biotechnology journal.

Aggregation of recombinant human interferon gamma: kinetics and structural transitions.

M. Manning, J. Carpenter, T. Randolph, 1998, Journal of pharmaceutical sciences.

Water-in-Carbon Dioxide Microemulsions: An Environment for Hydrophiles Including Proteins

Frank V. Bright, Keith P. Johnston, Steven M. Howdle, 1996, Science.

Microemulsions, Emulsions and Latexes

M. Z. Yates, K. Johnston, S. Rocha, 2007 .

Free-radical reactions in supercritical ethane : a probe of supercritical fluid structure

T. Randolph, C. Carlier, 1992 .

Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation.

M. Manning, J. Carpenter, E. Chi, 2005, Journal of pharmaceutical sciences.

A new mechanism for decreasing aggregation of recombinant human interferon-gamma by a surfactant: slowed dissolution of lyophilized formulations in a solution containing 0.03% polysorbate 20.

J. Carpenter, T. Randolph, J. Cleland, 2002, Journal of pharmaceutical sciences.

A transient expansion of the native state precedes aggregation of recombinant human interferon-gamma.

J. Carpenter, T. Randolph, J. Cleland, 1998, Proceedings of the National Academy of Sciences of the United States of America.

Evaluation of chemical degradation of a trivalent recombinant protein vaccine against botulinum neurotoxin by LysC peptide mapping and MALDI-TOF mass spectrometry.

J. Carpenter, R. Nayar, T. Randolph, 2009, Journal of pharmaceutical sciences.

Understanding and modulating opalescence and viscosity in a monoclonal antibody formulation.

Theodore W Randolph, Hasige A Sathish, John F Carpenter, 2010, Journal of pharmaceutical sciences.

Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2016, Journal of pharmaceutical sciences.

Nanobubbles in Reconstituted Lyophilized Formulations: Interaction With Proteins and Mechanism of Formation.

R. Suryanarayanan, T. Randolph, Jared R. Snell, 2020, Journal of pharmaceutical sciences.

Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose.

J. Carpenter, T. Randolph, W. Qi, 2016, Journal of pharmaceutical sciences.

Reduced Subvisible Particle Formation in Lyophilized Intravenous Immunoglobulin Formulations Containing Polysorbate 20.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2016, Journal of pharmaceutical sciences.

Protein quantity on the air-solid interface determines degradation rates of human growth hormone in lyophilized samples.

M. Pikal, J. Carpenter, T. Randolph, 2014, Journal of pharmaceutical sciences.

Storage stability of keratinocyte growth factor-2 in lyophilized formulations: effects of formulation physical properties and protein fraction at the solid-air interface.

J. Carpenter, T. Randolph, M. Cicerone, 2014, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Gelation of a monoclonal antibody at the silicone oil-water interface and subsequent rupture of the interfacial gel results in aggregation and particle formation.

Jared S. Bee, J. Carpenter, T. Randolph, 2015, Journal of pharmaceutical sciences.

Effects of tubing type, operating parameters and surfactants on particle formation during peristaltic filling pump processing of a monoclonal antibody formulation.

Krishna M. G. Mallela, Yannick Elias, J. Carpenter, 2020, Journal of pharmaceutical sciences.

Container surfaces control initiation of cavitation and resulting particle formation in protein formulations following application of mechanical shock.

C. Lengsfeld, T. Randolph, Hao Wu, 2019, Journal of pharmaceutical sciences.

Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues.

W. Jiskoot, D. Volkin, D. Crommelin, 2018, Journal of pharmaceutical sciences.

Effects of Tween 80 and Sucrose on Acute Short-Term Stability and Long-Term Storage at − 20 C of a Recombinant Hemoglobin

B. Kerwin, T. Randolph, M. C. Heller, 1998 .

Effects of Tween 80 and sucrose on acute short-term stability and long-term storage at -20 degrees C of a recombinant hemoglobin.

B. Kerwin, T. Randolph, M. C. Heller, 1998, Journal of pharmaceutical sciences.

Albinterferon α2b adsorption to silicone oil-water interfaces: effects on protein conformation, aggregation, and subvisible particle formation.

J. Carpenter, T. Randolph, PINAKI BASU, 2014, Journal of pharmaceutical sciences.

Immunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse Models.

R. Torres, J. Carpenter, T. Randolph, 2017, Journal of pharmaceutical sciences.

Silicone Oil Microdroplets Can Induce Antibody Responses Against Recombinant Murine Growth Hormone in Mice.

R. Torres, J. Carpenter, T. Randolph, 2016, Journal of pharmaceutical sciences.

In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations.

R. Torres, J. Carpenter, T. Randolph, 2015, Journal of pharmaceutical sciences.

Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives

J. Carpenter, T. Randolph, K. Izutsu, 1999 .

Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives

J. Carpenter, T. Randolph, K. Izutsu, 2004 .

Effects of benzyl alcohol on aggregation of recombinant human interleukin-1-receptor antagonist in reconstituted lyophilized formulations.

B. Kerwin, J. Carpenter, T. Randolph, 2005, Journal of pharmaceutical sciences.

Ultrasonic velocity measurements in supercritical jet fuel

T. Randolph, S. Natarajan, 1997 .

Water-in-carbon dioxide emulsions: Formation and stability

K. Johnston, C. T. Lee, T. Randolph, 1999 .

Water Core within Perfluoropolyether-Based Microemulsions Formed in Supercritical Carbon Dioxide

K. Johnston, F. Bright, M. Heitz, 1997 .

The Role of Protein Excipient in Driving Antibody Responses to Erythropoietin.

R. Torres, J. Carpenter, T. Randolph, 2015, Journal of pharmaceutical sciences.

Lyophilization of a triply unsaturated phospholipid: effects of trace metal contaminants.

J. Betker, T. Anchordoquy, M. Wempe, 2013, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Urea Improves Stability of Inactivated Polio Vaccine Serotype 3 During Lyophilization and Storage in Dried Formulations.

J. Carpenter, T. Randolph, W. Qi, 2018, Journal of pharmaceutical sciences.

Machine learning analysis provides insight into mechanisms of protein particle formation inside containers during mechanical agitation.

S. Ghazvini, C. Calderon, T. Randolph, 2022, Journal of pharmaceutical sciences.

Investigation of the Immunogenicity of Different Types of Aggregates of a Murine Monoclonal Antibody in Mice

M. Biel, G. Winter, S. Michalakis, 2014, Pharmaceutical Research.

Oxidation of methionine residues in recombinant human interleukin-1 receptor antagonist: implications of conformational stability on protein oxidation kinetics.

D. Brems, P. Bondarenko, J. Carpenter, 2007, Biochemistry.

Sedimentation velocity analytical ultracentrifugation and SEDFIT/c(s): limits of quantitation for a monoclonal antibody system.

John P. Gabrielson, T. Randolph, B. Kendrick, 2007, Analytical biochemistry.

Stability of Subtilisin and Lysozyme under High Hydrostatic Pressure

J. Carpenter, T. Randolph, J. N. Webb, 2000, Biotechnology progress.

In vitro and in vivo evaluation of the effects of PLA microparticle crystallinity on cellular response.

M. Manning, C. Lengsfeld, T. Randolph, 2003, Journal of controlled release : official journal of the Controlled Release Society.

Effects of phenol and meta-cresol depletion on insulin analog stability at physiological temperature.

J. Carpenter, T. Randolph, R. Pettis, 2014, Journal of pharmaceutical sciences.

Recombinant murine growth hormone from E. coli inclusion bodies: Expression, high‐pressure solubilization and refolding, and characterization of activity and structure

Amber Haynes Fradkin, S. Eisenberg, T. Randolph, 2010, Biotechnology progress.

Effect of pH on stability of recombinant botulinum serotype A vaccine in aqueous solution and during storage of freeze-dried formulations.

J. Carpenter, R. Nayar, T. Randolph, 2008, Journal of pharmaceutical sciences.

Conjugation of Emtansine Onto Trastuzumab Promotes Aggregation of the Antibody-Drug Conjugate by Reducing Repulsive Electrostatic Interactions and Increasing Hydrophobic Interactions.

J. Carpenter, T. Randolph, A. Gandhi, 2019, Journal of pharmaceutical sciences.

Thermostable Ebola virus vaccine formulations lyophilized in the presence of aluminum hydroxide

T. Randolph, T. Kang, M. Dong, 2019, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid.

S. Frokjaer, J. Flink, J. Carpenter, 1998, Archives of biochemistry and biophysics.

Stability of a trivalent recombinant protein vaccine formulation against botulinum neurotoxin during storage in aqueous solution.

J. Carpenter, R. Nayar, T. Randolph, 2009, Journal of pharmaceutical sciences.

Physical Instability of Peptides and Proteins

T. Randolph, M. Weert, 2012 .

Quantification of isoniazid and acetylisoniazid in rat plasma and alveolar macrophages by liquid chromatography-tandem mass spectrometry with on-line extraction.

Yan Ling Zhang, U. Christians, T. Randolph, 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Pressure dependence of subtilisin crystallization kinetics

C. Glatz, T. Randolph, M. Larson, 2000 .

Engineering challenges of protein formulations

J. Carpenter, T. Randolph, 2007 .

Effects of drying methods and additives on structure and function of actin: mechanisms of dehydration-induced damage and its inhibition.

K. Middleton, M. Manning, S. Allison, 1998, Archives of biochemistry and biophysics.

Investigations into the fouling mechanism of parvovirus filters during filtration of freeze-thawed mAb drug substance solutions.

J. Carpenter, T. Randolph, James G Barnard, 2014, Journal of pharmaceutical sciences.

Optimization of storage stability of lyophilized actin using combinations of disaccharides and dextran.

K. Middleton, M. Manning, S. Allison, 2000, Journal of pharmaceutical sciences.

Mechanism for benzyl alcohol-induced aggregation of recombinant human interleukin-1 receptor antagonist in aqueous solution.

B. Chang, M. Manning, B. Kerwin, 2004, Journal of Pharmacy and Science.

Antibody responses in mice to particles formed from adsorption of a murine monoclonal antibody onto glass microparticles.

G. Winter, J. Carpenter, T. Randolph, 2014, Journal of pharmaceutical sciences.

Glass particles as an adjuvant: a model for adverse immunogenicity of therapeutic proteins.

Amber Haynes Fradkin, J. Carpenter, T. Randolph, 2011, Journal of pharmaceutical sciences.

The effects of Tween 20 and sucrose on the stability of anti-L-selectin during lyophilization and reconstitution.

G. Winter, M. Manning, J. Carpenter, 2001, Journal of pharmaceutical sciences.

Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid.

S. Frokjaer, J. Flink, J. Carpenter, 1999, Journal of pharmaceutical sciences.

Conformational stability of lyophilized PEGylated proteins in a phase-separating system.

J. Carpenter, T. Randolph, M. C. Heller, 1999, Journal of pharmaceutical sciences.

Effects of phase separating systems on lyophilized hemoglobin.

J. Carpenter, T. Randolph, M. C. Heller, 1996, Journal of pharmaceutical sciences.

Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures.

N. Warne, J. Carpenter, S. Krishnan, 2004, Journal of pharmaceutical sciences.

Effect of zinc binding and precipitation on structures of recombinant human growth hormone and nerve growth factor.

M. Manning, J. Carpenter, T. Randolph, 2000, Journal of pharmaceutical sciences.

Microparticle-based lung delivery of INH decreases INH metabolism and targets alveolar macrophages.

U. Christians, M. Manning, T. Randolph, 2005, Journal of controlled release : official journal of the Controlled Release Society.

Stability of lyophilized and spray dried vaccine formulations.

T. Randolph, Kendall B. Preston, 2021, Advanced drug delivery reviews.

Process Variable Implications for Residual Solvent Removal and Polymer Morphology in the Formation of Gentamycin-Loaded Poly (L-lactide) Microparticles

T. Randolph, R. F. Falk, R. Falk, 1998, Pharmaceutical Research.

Common excipients impair detection of protein aggregates during sedimentation velocity analytical ultracentrifugation.

John P. Gabrielson, T. Randolph, Kelly K. Arthur, 2009, Journal of pharmaceutical sciences.

Influence of protein conformation and adjuvant aggregation on the effectiveness of aluminum hydroxide adjuvant in a model alkaline phosphatase vaccine.

A. Morin, J. Carpenter, T. Randolph, 2009, Journal of pharmaceutical sciences.

Molten Globule Intermediate of Recombinant Human Growth Hormone: Stabilization with Surfactants

T. Randolph, J. Cleland, N. Bam, 1996, Biotechnology progress.

Mechanism of polyethylene glycol interaction with the molten globule folding intermediate of bovine carbonic anhydrase B.

T. Randolph, J. Cleland, 1992, The Journal of biological chemistry.

Preformulation study of highly purified inactivated polio vaccine, serotype 3.

J. Carpenter, T. Randolph, W. Qi, 2014, Journal of pharmaceutical sciences.

Alveolar macrophage cell line is not activated by exposure to polymeric microspheres

D. Thompson, M. Manning, K. Stringer, 1998 .

Effect of benzyl alcohol on recombinant human interleukin-1 receptor antagonist structure and hydrogen-deuterium exchange.

D. Wuttke, R. F. Latypov, B. Kerwin, 2011, Journal of pharmaceutical sciences.

Effects of pH, temperature, and sucrose on benzyl alcohol-induced aggregation of recombinant human granulocyte colony stimulating factor.

D. Brems, J. Carpenter, S. Krishnan, 2006, Journal of pharmaceutical sciences.

Preparation and in vitro characterization of gentamycin-impregnated biodegradable beads suitable for treatment of osteomyelitis.

M. Manning, D. Kroll, T. Randolph, 1998, Journal of pharmaceutical sciences.

Effects of Tween 20 and Tween 80 on the stability of Albutropin during agitation.

M. Manning, Danny K. Chou, J. Carpenter, 2005, Journal of pharmaceutical sciences.

Computer Simulation of Convective and Diffusive Transport of Controlled-Release Drugs in the Vitreous Humor

Jing Xu, Victor H. Barocas, Theodore W. Randolph, 2004, Pharmaceutical Research.

Protein-solute interactions affect the outcome of ultrafiltration/diafiltration operations.

Theodore W Randolph, Brent S Kendrick, T. Randolph, 2004, Journal of pharmaceutical sciences.

Phase separation of excipients during lyophilization: effects on protein stability.

T. Randolph, T W Randolph, 1997, Journal of pharmaceutical sciences.

Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions.

Theodore W Randolph, Hanns-Christian Mahler, Christine Wurth, 2012, Journal of pharmaceutical sciences.

Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2010, Journal of pharmaceutical sciences.

Nucleation and growth rates of poly(L-lactic acid) microparticles during precipitation with a compressed-fluid antisolvent.

C. Lengsfeld, T. Randolph, D. Jarmer, 2004, Langmuir : the ACS journal of surfaces and colloids.

Contributions of local mobility and degree of retention of native secondary structure to the stability of recombinant human growth hormone (rhGH) in glassy lyophilized formulations

John F. Carpenter, Marcus T. Cicerone, Theodore W. Randolph, 2013 .

Rotational Relaxation in Supercritical Carbon Dioxide Revisited: A Study of Solute-Induced Local Density Augmentation

T. Randolph, J. deGrazia, J. A. O'Brien, 1998 .

Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T(g)' in pharmaceutical lyophilization.

J. Carpenter, T. Randolph, J A Searles, 2001, Journal of pharmaceutical sciences.

The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf.

J. Carpenter, T. Randolph, J A Searles, 2001, Journal of pharmaceutical sciences.

Enzymatic Oxidation of Cholesterol Aggregates in Supercritical Carbon Dioxide

J. Prausnitz, H. Blanch, D. Clark, 1988, Science.

Enzyme‐caytalyzed oxidation of cholesterol in supercritical carbon dioxide

J. Prausnitz, H. Blanch, T. Randolph, 1988 .

Cholesterol aggregation and interaction with cholesterol oxidase in supercritical carbon dioxide.

J. Prausnitz, H. Blanch, D. Clark, 1988, Proceedings of the National Academy of Sciences of the United States of America.

Particles shed from syringe filters and their effects on agitation-induced protein aggregation.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2012, Journal of pharmaceutical sciences.

Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding.

B. Chang, S. Allison, J. Carpenter, 1999, Archives of biochemistry and biophysics.

Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: role in restricted conformational mobility and compaction of native state.

B. Chang, M. Manning, J. Carpenter, 1997, Proceedings of the National Academy of Sciences of the United States of America.

High hydrostatic pressure as a tool to study protein aggregation and amyloidosis.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2002, Biochimica et biophysica acta.

Protein formulation and lyophilization cycle design: prevention of damage due to freeze-concentration induced phase separation.

J. Carpenter, T. Randolph, J F Carpenter, 1999, Biotechnology and bioengineering.

The effect of protein PEGylation on physical stability in liquid formulation.

Theodore W Randolph, J. E. Rasmussen, M. van de Weert, 2014, Journal of pharmaceutical sciences.

Molecular trajectories provide signatures of protein clustering and crowding at the oil/water interface.

D. K. Schwartz, T. Randolph, Aaron C Mcumber, 2015, Langmuir : the ACS journal of surfaces and colloids.

Rational design of stable lyophilized protein formulations: theory and practice.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2002, Pharmaceutical biotechnology.

Effects of Sugars and Polymers on Crystallization of Poly(ethylene glycol) in Frozen Solutions: Phase Separation Between Incompatible Polymers

J. Carpenter, T. Randolph, S. Yoshioka, 1996, Pharmaceutical Research.

Ca2+–Surfactant Interactions Affect Enzyme Stability in Detergent Solutions

T. Randolph, D. Dale, P. Gualfetti, 2005, Biotechnology progress.

Mechanism Governing Microparticle Morphology during Precipitation by a Compressed Antisolvent: Atomization vs Nucleation and Growth

V. Barocas, J. Delplanque, C. Lengsfeld, 2000 .

Steric Repulsion Forces Contributed by PEGylation of Interleukin-1 Receptor Antagonist Reduce Gelation and Aggregation at the Silicone Oil-Water Interface.

D. K. Schwartz, T. Randolph, Lea L Sorret, 2019, Journal of pharmaceutical sciences.

Enzymatic catalysis in a supercritical fluid

J. Prausnitz, H. Blanch, C. Wilke, 1985, Biotechnology Letters.

Surface adsorption of recombinant human interferon-gamma in lyophilized and spray-lyophilized formulations.

Theodore W Randolph, John F Carpenter, S. Golledge, 2002, Journal of pharmaceutical sciences.

Protein instability and immunogenicity: roadblocks to clinical application of injectable protein delivery systems for sustained release.

Theodore W Randolph, C Russell Middaugh, Wim Jiskoot, 2012, Journal of pharmaceutical sciences.

Temperature dependence of benzyl alcohol- and 8-anilinonaphthalene-1-sulfonate-induced aggregation of recombinant human interleukin-1 receptor antagonist.

D. Katayama, B. Kerwin, J. Carpenter, 2006, Biochemistry.

Effect of salts and sugars on phase separation of polyvinylpyrrolidone[ndash ]dextran solutions induced by freeze-concentration

J. Carpenter, T. Randolph, K. Izutsu, 1998 .

Glassy-state stabilization of a dominant negative inhibitor anthrax vaccine containing aluminum hydroxide and glycopyranoside lipid A adjuvants.

Theodore W Randolph, C Russell Middaugh, Lilia A. Rabia, 2015, Journal of pharmaceutical sciences.

Inhibition of aggregation of aluminum hydroxide adjuvant during freezing and drying.

J. Carpenter, T. Randolph, Scott A. Merkley, 2008, Journal of pharmaceutical sciences.

Stability of Protein Formulations: Investigation of Surfactant Effects by a Novel EPR Spectroscopic Technique

T. Randolph, J. Cleland, N. Bam, 2004, Pharmaceutical Research.

Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing.

J. Carpenter, L. Kueltzo, T. Randolph, 2008, Journal of pharmaceutical sciences.

Challenges in Predicting Protein-Protein Interactions from Measurements of Molecular Diffusivity.

Theodore W Randolph, D. K. Schwartz, T. Randolph, 2016, Biophysical journal.

Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice

Michael J. Pikal, John F. Carpenter, Theodore W. Randolph, 1997, Pharmaceutical Research.

Carbonaceous Deposit Formation from Advanced Fuels Under Supercritical Conditions

L. Pfefferle, T. Randolph, 1997 .

Effects of surfaces and leachables on the stability of biopharmaceuticals.

Jared S. Bee, S. Bishop, J. Carpenter, 2011, Journal of pharmaceutical sciences.

Quasicritical behavior of dense-gas solventsolute clusters at near-infinite dilution

T. Randolph, C. Carlier, J. A. O'Brien, 1993 .

Dense‐gas solvent‐solute clusters at near‐infinite dilution: EPR spectroscopic evidence

T. Randolph, C. Carlier, 1993 .

Molecular simulation and electron paramagnetic resonance (EPR) studies of rapid bimolecular reactions in supercritical fluids

T. Randolph, C. Carlier, J. A. O'Brien, 1996 .

Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity.

John P. Gabrielson, G. Winter, J. Carpenter, 2007, Journal of pharmaceutical sciences.

Quaternary conformational stability: The effect of reversible self‐association on the fibrillation of two insulin analogs

J. Carpenter, T. Randolph, C. Fernández, 2011, Biotechnology and bioengineering.

Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony‐stimulating factor

Theodore W Randolph, Brent S Kendrick, Eva Y Chi, 2003, Protein science : a publication of the Protein Society.

Surfactant Effects on Particle Generation in Antibody Formulations in Pre-filled Syringes.

Theodore W Randolph, John F Carpenter, D. K. Schwartz, 2015, Journal of pharmaceutical sciences.

Selective domain stabilization as a strategy to reduce fusion protein aggregation.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2012, Journal of pharmaceutical sciences.

Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene.

W. Jiskoot, T. Randolph, H. Schellekens, 2012, Journal of pharmaceutical sciences.

Refolding of proteins from inclusion bodies is favored by a diminished hydrophobic effect at elevated pressures

T. Randolph, Ryan L. Crisman, Ryan L. Crisman, 2009, Biotechnology and bioengineering.

Buffer-dependent fragmentation of a humanized full-length monoclonal antibody.

Theodore W Randolph, Hasige A Sathish, John F Carpenter, 2010, Journal of pharmaceutical sciences.

Physical stability of albinterferon-α(2b) in aqueous solution: effects of conformational stability and colloidal stability on aggregation.

Theodore W Randolph, John F Carpenter, Danny K Chou, 2012, Journal of pharmaceutical sciences.

Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions.

J L Cleland, M C Manning, R. Kelley, 1998, Journal of pharmaceutical sciences.

Investigation of the Immunogenicity of Different Types of Aggregates of a Murine Monoclonal Antibody in Mice

M. Biel, G. Winter, S. Michalakis, 2015, Pharmaceutical Research.

Strategies for Bulk Storage and Shipment of Proteins

T. Randolph, F. Jameel, Chakradhar Padala, 2010 .

Surfactant-protein interactions.

Theodore W Randolph, T. Randolph, L. Jones, 2002, Pharmaceutical biotechnology.

Immunogenicity of aggregates of recombinant human growth hormone in mouse models.

Amber Haynes Fradkin, Theodore W Randolph, John F Carpenter, 2009, Journal of pharmaceutical sciences.

High concentration formulations of recombinant human interleukin-1 receptor antagonist: I. Physical characterization.

D. Wuttke, J. Carpenter, T. Randolph, 2008, Journal of pharmaceutical sciences.

Influence of particle size and antigen binding on effectiveness of aluminum salt adjuvants in a model lysozyme vaccine.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2008, Journal of pharmaceutical sciences.

Effects of solution conditions and surface chemistry on the adsorption of three recombinant botulinum neurotoxin antigens to aluminum salt adjuvants.

J. Carpenter, R. Nayar, T. Randolph, 2007, Journal of pharmaceutical sciences.

Development of a highly thermostable, adjuvanted human papillomavirus vaccine.

Kimberly J. Hassett, R. Garcea, F. Semmelmann, 2015, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Stabilization of a recombinant ricin toxin A subunit vaccine through lyophilization.

Lilia A. Rabia, Kimberly J. Hassett, N. Mantis, 2013, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Microflow Imaging Analyses Reflect Mechanisms of Aggregate Formation: Comparing Protein Particle Data Sets Using the Kullback-Leibler Divergence.

Nathaniel R Maddux, Austin L Daniels, Theodore W Randolph, 2017, Journal of pharmaceutical sciences.

Inhibition of stress-induced aggregation of protein therapeutics.

M C Manning, B. Chang, M. Manning, 1999, Methods in enzymology.

Counteracting Effects of Renal Solutes on Amyloid Fibril Formation by Immunoglobulin Light Chains*

M. Manning, J. Carpenter, E. Chi, 2001, The Journal of Biological Chemistry.

Physical instability of a therapeutic Fc fusion protein: domain contributions to conformational and colloidal stability.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2009, Biochemistry.

Manipulation of particle size distribution of poly(l-lactic acid) nanoparticles with a jet-swirl nozzle during precipitation with a compressed antisolvent

Corinne S. Lengsfeld, Theodore W. Randolph, Daniel J. Jarmer, 2003 .

Maintenance of quaternary structure in the frozen state stabilizes lactate dehydrogenase during freeze-drying.

T. Anchordoquy, J. Carpenter, T. Randolph, 2001, Archives of biochemistry and biophysics.

Response to Comment to the Editor.

T. Randolph, 2017, Biophysical journal.

Inhibition of agitation-induced aggregation of an IgG-antibody by hydroxypropyl-beta-cyclodextrin.

Theodore W Randolph, Gerhard Winter, John F Carpenter, 2010, Journal of pharmaceutical sciences.

Precipitation of a monoclonal antibody by soluble tungsten.

Theodore W Randolph, Erwin Freund, John F Carpenter, 2009, Journal of pharmaceutical sciences.

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

Steven Kozlowski, Theodore W Randolph, C Russell Middaugh, 2009, Journal of pharmaceutical sciences.

Permeability and Diffusion in Vitreous Humor: Implications for Drug Delivery

Jing Xu, Jeffrey J. Heys, Victor H. Barocas, 2004, Pharmaceutical Research.

Deep Convolutional Neural Network Analysis of Flow Imaging Microscopy Data to Classify Subvisible Particles in Protein Formulations.

Austin L Daniels, Theodore W Randolph, Christopher P Calderon, 2017, Journal of pharmaceutical sciences.

Freezing-induced perturbation of tertiary structure of a monoclonal antibody.

Theodore W Randolph, Wei Wang, John F Carpenter, 2014, Journal of pharmaceutical sciences.

Protein aggregation and particle formation in prefilled glass syringes.

Theodore W Randolph, John F Carpenter, Jared S. Bee, 2014, Journal of pharmaceutical sciences.

IgG particle formation during filling pump operation: a case study of heterogeneous nucleation on stainless steel nanoparticles.

Theodore W Randolph, John F Carpenter, A. Tyagi, 2009, Journal of pharmaceutical sciences.

Recombinant murine growth hormone particles are more immunogenic with intravenous than subcutaneous administration.

R. Torres, J. Carpenter, T. Randolph, 2014, Journal of pharmaceutical sciences.

DEHP Nanodroplets Leached from Polyvinyl Chloride IV Bags Promote Aggregation of IVIG and Activate Complement in Human Serum.

J. Carpenter, T. Randolph, A. Frazer-Abel, 2020, Journal of pharmaceutical sciences.

High Pressure Refolding of Recombinant Human Growth Hormone from Insoluble Aggregates

J. Carpenter, T. Randolph, C. Balny, 2001, The Journal of Biological Chemistry.

High pressure fosters protein refolding from aggregates at high concentrations.

J. Carpenter, T. Randolph, J F Carpenter, 1999, Proceedings of the National Academy of Sciences of the United States of America.

Single-administration, thermostable human papillomavirus vaccines prepared with atomic layer deposition technology

R. Garcea, S. Ghazvini, T. Randolph, 2020, npj Vaccines.

Single-administration, thermostable human papillomavirus vaccines prepared with atomic layer deposition technology

R. Garcea, S. Ghazvini, T. Randolph, 2020, npj Vaccines.

A Single Dose, Thermostable, Trivalent Human Papillomavirus Vaccine Formulated Using Atomic Layer Deposition.

R. Garcea, T. Randolph, Alyssa E. Witeof, 2023, Journal of pharmaceutical sciences.

Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization.

J. Carpenter, T. Randolph, J F Carpenter, 1999, Archives of Biochemistry and Biophysics.

Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution.

Theodore W Randolph, John F Carpenter, D. Brems, 2009, Journal of pharmaceutical sciences.

Protein Aggregation and Particle Formation: Effects of Formulation, Interfaces, and Drug Product Manufacturing Operations

Stefan Fischer, J. Carpenter, T. Randolph, 2010 .

Insulin Fibril Formation Caused by Mechanical Shock and Cavitation.

Andrew P. Goodwin, T. Randolph, Hao Wu, 2021, The journal of physical chemistry. B.

Degradation kinetics of high molecular weight poly(L-lactide) microspheres and release mechanism of lipid:DNA complexes.

Mayank M. Patel, T. Anchordoquy, M. Manning, 2004, Journal of pharmaceutical sciences.

Mixing properties of lyophilized protein systems: a spectroscopic and calorimetric study.

K. Menard, M. Manning, D. Katayama, 2009, Journal of pharmaceutical sciences.

Aggregation of granulocyte colony stimulating factor under physiological conditions: characterization and thermodynamic inhibition.

Theodore W Randolph, Mark C Manning, Eva Y Chi, 2002, Biochemistry.

Effects of sucrose on conformational equilibria and fluctuations within the native‐state ensemble of proteins

B. Chang, M. Manning, J. Carpenter, 2003, Protein science : a publication of the Protein Society.

Surfactant‐Induced Unfolding of Cellulase: Kinetic Studies

T. Randolph, D. Dale, P. Gualfetti, 2006, Biotechnology progress.

Protease autolysis in heavy-duty liquid detergent formulations: effects of thermodynamic stabilizers and protease inhibitors

M. Manning, J. Carpenter, T. Randolph, 2004 .

Response of a concentrated monoclonal antibody formulation to high shear

Joey Pollastrini, Erwin Freund, Bhavya Mehta, 2009, Biotechnology and bioengineering.

The excluding effects of sucrose on a protein chemical degradation pathway: methionine oxidation in subtilisin.

A. Gaertner, J. Carpenter, T. Randolph, 2000, Archives of biochemistry and biophysics.

Manipulation of Lyophilization‐Induced Phase Separation: Implications For Pharmaceutical Proteins

J. Carpenter, T. Randolph, J F Carpenter, 1997, Biotechnology progress.

Thermodynamic Modulation of Light Chain Amyloid Fibril Formation*

M. Manning, J. Carpenter, T. Randolph, 2000, The Journal of Biological Chemistry.

Surfactant-Stabilized Protein Formulations: A Review of Protein-Surfactant Interactions and Novel Analytical Methodologies

T. Randolph, L. Jones, N. Bam, 1997 .

Protein–protein interactions controlling interfacial aggregation of rhIL‐1ra are not described by simple colloid models

D. K. Schwartz, T. Randolph, Lea L Sorret, 2018, Protein science : a publication of the Protein Society.

Pressure Control of Reactions in Supercritical Fluids: Thermodynamics and Kinetics

T. Randolph, C. Carlier, 1992 .

Monoclonal antibody interactions with micro- and nanoparticles: adsorption, aggregation, and accelerated stress studies.

Jared S. Bee, J. Carpenter, T. Randolph, 2009, Journal of pharmaceutical sciences.

Production of particles of therapeutic proteins at the air–water interface during compression/dilation cycles

Jared S. Bee, D. K. Schwartz, J. Carpenter, 2012 .

Dose levels in particulate-containing formulations impact anti-drug antibody responses to murine monoclonal antibody in mice.

G. Winter, J. Carpenter, T. Randolph, 2015, Journal of pharmaceutical sciences.

IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: a model for siliconized primary containers.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2013, Journal of pharmaceutical sciences.

Testing Precision Limits of Neural Network-Based Quality Control Metrics in High-Throughput Digital Microscopy

Charudharshini Srinivasan, C. Calderon, T. Randolph, 2022, Pharmaceutical Research.

Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces.

Jared S. Bee, J. Carpenter, T. Randolph, 2013, Journal of pharmaceutical sciences.

Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway.

Theodore W Randolph, John F Carpenter, S. Singh, 2011, Journal of pharmaceutical sciences.

Flow cytometry: a promising technique for the study of silicone oil-induced particulate formation in protein formulations.

Theodore W Randolph, John P. Gabrielson, John F Carpenter, 2011, Analytical biochemistry.

UV photodegradation of murine growth hormone: chemical analysis and immunogenicity consequences.

Amber Haynes Fradkin, Theodore W Randolph, John F Carpenter, 2014, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Pressure effect on subtilisin crystallization and solubility

C. Glatz, J. Carpenter, T. Randolph, 1999 .

Supercritical fluid crystallization of griseofulvin: crystal habit modification with a selective growth inhibitor.

Theodore W Randolph, Kristi S Anseth, K. Anseth, 2005, Journal of pharmaceutical sciences.

Therapeutic protein and peptide formulation and delivery

Z. Shahrokh, T. Randolph, J. Cleland, 1997 .

Oxidative dimer formation is the critical rate-limiting step for Parkinson's disease alpha-synuclein fibrillogenesis.

Theodore W Randolph, Brent S Kendrick, Eva Y Chi, 2003, Biochemistry.

Hydrophobic ion pairing of isoniazid using a prodrug approach.

M. Manning, C. Lengsfeld, T. Randolph, 2002, Journal of pharmaceutical sciences.

Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2015, Journal of pharmaceutical sciences.

Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2016, Journal of pharmaceutical sciences.

Measurement of the second osmotic virial coefficient for protein solutions exhibiting monomer-dimer equilibrium.

J. Carpenter, T. Randolph, B. Kendrick, 2008, Analytical biochemistry.

Single-vial filovirus glycoprotein vaccines: Biophysical characteristics and immunogenicity after co-lyophilization with adjuvant.

O. Donini, T. Randolph, J. Yalley-Ogunro, 2021, Vaccine.

Protein Nanoparticles Promote Microparticle Formation in Intravenous Immunoglobulin Solutions During Freeze-Thawing and Agitation Stresses.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2018, Journal of pharmaceutical sciences.

Machine learning and statistical analyses for extracting and characterizing “fingerprints” of antibody aggregation at container interfaces from flow microscopy images

Austin L Daniels, Theodore W Randolph, Christopher P Calderon, 2020, Biotechnology and bioengineering.

Specific volume and adiabatic compressibility measurements of native and aggregated recombinant human interleukin‐1 receptor antagonist: Density differences enable pressure‐modulated refolding

T. Randolph, Matthew B Seefeldt, B. Kendrick, 2007, Biotechnology and bioengineering.

High‐Pressure Refolding of Disulfide‐Cross‐Linked Lysozyme Aggregates: Thermodynamics and Optimization

J. Carpenter, T. Randolph, Richard J. St. John, 2002, Biotechnology progress.

Aggregation of a monoclonal antibody induced by adsorption to stainless steel

Theodore W Randolph, Erwin Freund, John F Carpenter, 2010, Biotechnology and bioengineering.

High‐pressure studies of aggregation of recombinant human interleukin‐1 receptor antagonist: Thermodynamics, kinetics, and application to accelerated formulation studies

J. Carpenter, T. Randolph, J. Seely, 2005, Protein science : a publication of the Protein Society.

Partial molar volume, surface area, and hydration changes for equilibrium unfolding and formation of aggregation transition state: High-pressure and cosolute studies on recombinant human IFN-γ

J. Carpenter, T. Randolph, J. Cleland, 2001, Proceedings of the National Academy of Sciences of the United States of America.

High-pressure studies on protein aggregates and amyloid fibrils.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2006, Methods in Enzymology.

Effects of solution conditions on methionine oxidation in albinterferon alfa-2b and the role of oxidation in its conformation and aggregation.

M. Manning, Danny K. Chou, J. Carpenter, 2013, Journal of pharmaceutical sciences.

The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study.

Theodore W Randolph, John F Carpenter, D. K. Schwartz, 2013, Journal of pharmaceutical sciences.

The two faces of His‐tag: Immune response versus ease of protein purification

T. Randolph, 2012, Biotechnology journal.

Effects of solutes on solubilization and refolding of proteins from inclusion bodies with high hydrostatic pressure

B. Chang, J. Carpenter, T. Randolph, 2006, Protein science : a publication of the Protein Society.

Machine learning approaches to root cause analysis, characterization, and monitoring of subvisible particles in monoclonal antibody formulations

C. Calderon, T. Randolph, Jingtao Zhang, 2022, Biotechnology and bioengineering.

Entrapping intermediates of thermal aggregation in alpha-helical proteins with low concentration of guanidine hydrochloride.

J. Carpenter, T. Randolph, A. Dong, 2000, The Journal of biological chemistry.

Kinetics and Energetics of Assembly, Nucleation, and Growth of Aggregates and Fibrils for an Amyloidogenic Protein

J. Carpenter, T. Randolph, F. Stevens, 2002, The Journal of Biological Chemistry.

Aggregation of recombinant human botulinum protein antigen serotype C in varying solution conditions: implications of conformational stability for aggregation kinetics.

Theodore W Randolph, John F Carpenter, Shujun Bai, 2011, Journal of pharmaceutical sciences.

Effects of annealing lyophilized and spray-lyophilized formulations of recombinant human interferon-gamma.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2003, Journal of pharmaceutical sciences.

High‐pressure refolding of bikunin: Efficacy and thermodynamics

J. Ouyang, J. Carpenter, T. Randolph, 2004, Protein science : a publication of the Protein Society.

Crystallization of recombinant human growth hormone at elevated pressures: Pressure effects on PEG‐induced volume exclusion interactions

T. Randolph, Ryan L. Crisman, 2010, Biotechnology and bioengineering.

Formulation Approaches and Strategies for Vaccines and Adjuvants

Pradyot Nandi, Kimberly J. Hassett, Theodore W. Randolph, 2013 .

Partial unfolding of a monoclonal antibody: role of a single domain in driving protein aggregation.

Jared S. Bee, J. Carpenter, T. Randolph, 2014, Biochemistry.

Selective domain stabilization as a strategy to reduce human serum albumin-human granulocyte colony stimulating factor aggregation rate.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2012, Journal of pharmaceutical sciences.

Interfacial Adsorption Controls Particle Formation in Antibody Formulations Subjected to Extensional Flows and Hydrodynamic Shear

S. Ghazvini, C. Calderon, T. Randolph, 2023, Journal of Pharmaceutical Sciences.

Impact of heat treatment on miscibility of proteins and disaccharides in frozen solutions.

Chikako Yomota, Theodore W Randolph, John F Carpenter, 2013, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.

D. Grier, K. Benkstein, W. Jiskoot, 2021, Journal of pharmaceutical sciences.

Role of electrostatic repulsion on colloidal stability of Bacillus halmapalus alpha-amylase.

Peter Westh, John F Carpenter, P. Westh, 2009, Biochimica et biophysica acta.

Long‐Term Storage of Proteins

Theodore W Randolph, John F Carpenter, Mark C Manning, 2002, Current protocols in protein science.

Machine learning and accelerated stress approaches to differentiate potential causes of aggregation in polyclonal antibody formulations during shipping.

Austin L Daniels, C. Calderon, T. Randolph, 2021, Journal of pharmaceutical sciences.

Population balance modeling of aggregation kinetics of recombinant human interleukin-1 receptor antagonist.

Theodore W Randolph, Brent S Kendrick, Eva Y Chi, 2005, Journal of pharmaceutical sciences.

Adsorption of monoclonal antibodies to glass microparticles.

Theodore W Randolph, Hanns-Christian Mahler, Christine Wurth, 2011, Journal of pharmaceutical sciences.

Encapsulating DNA within biodegradable polymeric microparticles.

M. Manning, C. Lengsfeld, T. Randolph, 2002, Current Pharmaceutical Biotechnology.

Lyophilized Filovirus Glycoprotein Vaccines: Peroxides in a Vaccine Formulation with Polysorbate 80-containing Adjuvant are Associated with Reduced Neutralizing Antibody Titers in both Mice and Non-human Primates.

O. Donini, H. Andersen, T. Randolph, 2022, Journal of pharmaceutical sciences.

High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics.

Theodore W Randolph, Brent S Kendrick, John F Carpenter, 2008, Journal of pharmaceutical sciences.

Accelerated stability studies of abatacept formulations: comparison of freeze-thawing- and agitation-induced stresses.

Theodore W Randolph, John F Carpenter, J. Carpenter, 2012, Journal of pharmaceutical sciences.

Electrostatic Interactions Influence Protein Adsorption (but Not Desorption) at the Silica-Aqueous Interface.

Theodore W Randolph, D. K. Schwartz, T. Randolph, 2015, The journal of physical chemistry letters.

Rapid Quantification of Protein Particles in High-Concentration Antibody Formulations.

T. Randolph, Hao Wu, 2019, Journal of pharmaceutical sciences.

Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions.

J. Carpenter, T. Randolph, Jared R. Snell, 2016, Journal of pharmaceutical sciences.

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

Patrick G. Swann, W. Jiskoot, G. Winter, 2009, Journal of pharmaceutical sciences.

Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces.

J. Carpenter, T. Randolph, Shyam B. Mehta, 2016, Journal of pharmaceutical sciences.

Aggregation of amphipathic peptides at an aqueous–organic interface using coarse-grained simulations

C. Hall, T. Randolph, David C. Latshaw, 2017 .

Do not drop: mechanical shock in vials causes cavitation, protein aggregation, and particle formation.

Donn R. Sederstrom, J. Carpenter, T. Randolph, 2015, Journal of pharmaceutical sciences.

Refolding of proteins from inclusion bodies is favored by a diminished hydrophobic effect at elevated pressures

T. Randolph, Ryan L. Crisman, 2009, Biotechnology and bioengineering.

IgG particle formation during filling pump operation: a case study of heterogeneous nucleation on stainless steel nanoparticles.

A. Tyagi, K. Maloney, J. Carpenter, 2009, Journal of pharmaceutical sciences.

Testing Precision Limits of Neural Network-Based Quality Control Metrics in High-Throughput Digital Microscopy

Charudharshini Srinivasan, C. Calderon, T. Randolph, 2022, Pharmaceutical Research.

Effects of solution conditions on methionine oxidation in albinterferon alfa-2b and the role of oxidation in its conformation and aggregation.

M. Manning, Danny K. Chou, J. Carpenter, 2013, Journal of pharmaceutical sciences.

Do solute-solute interactions affect activation-limited reactions? A Brownian dynamics study

T. Randolph, J. A. O'Brien, S. Ganapathy, 1996 .

Dissolution and Partitioning Behavior of Hydrophobic Ion-Paired Compounds

D. Pitera, C. Lengsfeld, T. Randolph, 2002, Pharmaceutical Research.

Does Critical Clustering Affect Reaction Rate Constants? Molecular Dynamics Studies in Pure Supercritical Fluids

T. Randolph, J. A. O'Brien, S. Ganapathy, 1994 .